BEUDAMED
    19 results · 48ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Subtle Medical Inc

    FDA registration
    Subtle Medical Inc·4 products·🇺🇸 United States

    SubtleMR

    FDA UDI
    Subtle Medical, Inc.·00860000171212·SubtleMR is an image processing software that c...

    SubtlePET

    FDA UDI
    Subtle Medical, Inc.·00860000171205·SubtlePET is an image processing software inten...

    AiMIFY

    FDA UDI
    Subtle Medical, Inc.·00860000171298·AiMIFY is an image processing software that can...

    SubtleSYNTH

    FDA UDI
    Subtle Medical, Inc.·00860000171229·SubtleSYNTH is a software as a medical device c...

    SubtleALIGN

    FDA UDI
    Subtle Medical, Inc.·00860000171236·SubtleALIGN is a radiology image reformatting s...

    SubtleHD(MR)

    FDA UDI
    Subtle Medical, Inc.·00860000171243·SubtleHD is an image processing software that c...

    COULTER HMX ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·May 25, 2012

    RSP

    FDA Adverse Event
    Injury ·ENCORE MEDICAL L.P·Product code PHX·October 1, 2021

    Bard Mesh Monofilament Knitted Polypropylene; size 10 x 14", 3 units per box; Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    FDA Recall
    Terminated ·Ram Medical Inc·Product code FTL·March 5, 2010

    Bard Mesh Monofilament Knitted Polypropylene Flat Mesh; size 6" x 6", 3 per box; Davol Inc., Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    FDA Recall
    Terminated ·Ram Medical Inc·Product code FTL·March 5, 2010

    Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Davol Inc. A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    FDA Recall
    Terminated ·Ram Medical Inc·Product code FTL·March 5, 2010

    Bard Mesh Monofilament Knitted Polypropylene; Contents: size 2" x 4", 3 units per box, Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    FDA Recall
    Terminated ·Ram Medical Inc·Product code FTL·March 5, 2010

    TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITYTM DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·October 1, 2025

    INPEN MMT-105ELBLNA ELI LILY BLUE

    FDA Adverse Event
    Malfunction ·COMPANION MEDICAL INC·Product code FMF·June 1, 2021

    INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code KGC·February 11, 2022

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·April 4, 2024

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·May 13, 2024

    PULSE GEN MODEL 106

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·April 14, 2023